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Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0 (APPOINT 2.0): A Multi-center Randomized Controlled Trial
Who can join
Ages 15 to 45 · Women
Full eligibility criteria
Inclusion Criteria: * BMI ≥30 * No prior deliveries at or beyond 20 weeks gestation * Undergoing induction of labor * Gestational age 37 weeks or more * Age 15-45 * Not receiving IAP for GBS prophylaxis Exclusion Criteria: * Fetal death prior to labor induction * Known fetal anomaly * Multiple gestation * Ruptured membranes for more than 12 hours * Chorioamnionitis or other infection requiring antibiotics at the start of the labor induction * Previous myometrial surgery * Allergy to azithromycin or beta-lactam antibiotics
About the study
Obesity increases the risk of pregnancy complications, including puerperal infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Since obese women are more likely to have comorbidities that would necessitate delivery prior to their due date (i.e. prior to 40 weeks gestation), and class III obesity specifically is an indication for delivery by 39 weeks, these patients have a high rate of labor induction. In nulliparous women from the general population (obese and non-obese), labor induction at 39 weeks (compared to expectant management) is associated with less maternal morbidity and a lower cesarean rate. Researchers previously conducted a pilot randomized placebo-controlled trial in obese, nulliparous women undergoing labor induction at term and found that the cesarean delivery rate was lower in women who received a prophylactic antibiotic regimen during labor compared with those who received the placebo. Researchers proposed multi-center trial aims to test this hypothesis in a large sample with adequate power to determine whether prophylactic antibiotics during labor are associated with a decrease in the rate of cesarean delivery in term, nulliparous, obese women. If the findings from the pilot trial are confirmed, this would represent a novel intervention to decrease the cesarean delivery rate in a subset of women at highest risk for cesarean-related complications.
What is being tested
- Azithromycin (drug)
- Placebo (drug)
Sponsor: University of Oklahoma · Participants: 787 · Started: Apr 29, 2025
Contact the study team
- Stephanie Pierce, MD · Phone: 405-271-8787
- Christy Zornes, MHR · Phone: 405-271-8001
Official record on ClinicalTrials.gov — NCT06488781
Locations in the U.S.
| Oklahoma | University of Oklahoma Health Sciences Center, Oklahoma City |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.